N/A
Completed N=672
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea
Diphtheria-Tetanus-acellular Pertussis Vaccines
Source: ClinicalTrials.gov NCT01929291 ↗
Enrolled (actual)
672
Serious AEs
0.9%
Results posted
Mar 2019
Primary outcomePrimary: Number of Unexpected Adverse Events (AEs) — 65 Events
Summary
The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Unexpected Adverse Events (AEs) |
65 | — |
| PRIMARY Number of Expected AEs. |
59 | — |
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
6 | — |
Eligibility Criteria
Inclusion Criteria
- Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.
Exclusion Criteria
- Those who are not eligible for vaccination according to the local Prescribing Information.
- Child in care.
Data sourced from ClinicalTrials.gov (NCT01929291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.